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The US Food and Drug Administration (FDA) approved linaclotide earlier this month for the treatment of patients with functional constipation aged 6-17 years.
Earlier this week, the US Food and Drug Administration (FDA) approved linaclotide (Linzess) capsules for pediatric patients with functional constipation, aged 6-17 years, making it the first ever treatment to garner FDA approval for this patient population.
The treatment, while unlikely to be the first-line option, will go a long way toward meeting an unmet need of patients who do not respond to some of the alternative treatment options commonly used, including osmotic laxatives.
The recommended dosage is 72 mcg orally once daily.
In an interview with HCPLive®, Jeffrey Hyams, MD, Division Head of Gastroenterology, Connecticut Children’s, explained the importance of the approval for pediatric patients with functional constipation.
“You have to remember that pediatricians have been limited in the agents they have to treat constipation,” Hyams said. “The pediatric world is not the same as the adult world. [Linaclotide] gives us a unique mechanism of action.”
Hyams said the main reason the treatment is unlikely to be a top of the line treatment for pediatric patients with functional constipation is that some of the laxatives and other alternatives are much cheaper. However, when a patient does not respond to those options, linaclotide would be next in line.